The Ethics of Sham Surgery in Clinical Orthopaedic Research

Abstract

While other surgical specialties, such as neurosurgery and thoracic surgery, have already broached the ethical discussion surrounding sham surgery as a research method, published discussion regarding the use of the sham orthopaedic model has been limited1. One solution in orthopaedics would be to open up the debate and the decision-making process to the surgeons, as there is no current forum or body to do this2. An essential question in the debate on the ethics of sham surgery concerns resolving the tension between the highest standard of research design (the double-blind, randomized, placebo-controlled trial) and the highest standard of ethics (to do no harm to the patient)3. We use published orthopaedic studies to analyze the ethical issues that pertain to sham surgery as a methodology in orthopaedic research. In addition, we provide a foundation for the orthopaedic surgeon on the subject of sham surgery as a research tool. Our goal is to advance both the discussion and the understanding of the ethical issues surrounding sham orthopaedic surgery as it applies to orthopaedic surgeons and their patients. Few physicians and researchers would deny the existence of the sham (placebo) surgery effect. However, the degree to which the placebo effect impacts outcomes is not completely understood. A comprehensive metaanalysis of research on the placebo effect indicated that subjective outcomes can be attributable to “placebo” effects or bias4,5. Therefore, a study that evaluates treatment outcomes should account for the placebo effect5. These findings are relevant to a discussion involving outcome measures in orthopaedic surgery, as subjective measures such as function and pain are frequently used in clinical orthopaedic studies6,7. These measures are often difficult to gauge objectively. The variable and subjective nature of pain and function lacks the …